Section 15 of the Safety Data Sheet – What Information Must Be Included?
Creating safety data sheets in compliance with applicable regulations is not just a formality – it is a key element of chemical safety. One of the often overlooked but important sections of the SDS is Section 15: Regulatory information.
This article explains what exactly should be included in this section and why its correct completion is important nonetheless.
What is Section 15 of the Safety Data Sheet?
Section 15 is the penultimate part of the SDS. Its purpose is to present information arising from legal regulations that are not included in other sections of the document.
This applies to both EU legislation and national requirements – all to help the user determine whether and what restrictions or obligations apply to a given substance or mixture. This allows them to assess if and how the product can be placed on the market, as well as what additional requirements may be relevant.
What does Section 15 of the Safety Data Sheet include?
According to Annex II to the REACH Regulation (2020/878), Section 15 should consist of two subsections:
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
This part should list:
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EU legislation applicable to the substance/mixture, such as:
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inclusion under restriction (Annex XVII to REACH) or subject to authorisation (Annex XIV to REACH),
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SVHC status – substances of very high concern,
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sectoral regulations, e.g. the Detergents Regulation, Biocidal Products Regulation, Medical Devices Regulation, Waste Framework Directive.
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National legislation that may impact the use of the product, for example:
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water hazard classification (WGK – Germany),
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storage classes,
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national lists of occupational diseases.
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🔎 Practical tip: Although often neglected, this part of the SDS may be crucial for the recipient – such as an importer or distributor who needs to know whether the product can be legally placed on the market.
15.2 Chemical Safety Assessment (CSA)
This subsection should indicate whether a chemical safety assessment has been carried out for the substance in accordance with REACH:
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If a CSA has been conducted – this should be clearly indicated.
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If a CSA has not been conducted – this must also be clearly stated.
💡 This requirement mainly applies to substances. In the case of mixtures, you may indicate whether the individual components have been assessed.
What does this mean in practice?
✔ When preparing a safety data sheet, do not skip Section 15 – its absence or incompleteness may result in a formal non-compliance finding during inspection.
✔ The manufacturer, importer, or party responsible for the SDS should be aware of:
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the regulatory status of the substance or mixture,
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applicable restrictions and any possible exemptions.
Summary
If you're involved in creating safety data sheets, remember that Section 15 is not just a formality. Properly completed, it helps end users comply with legal requirements and avoid penalties.
📌 A complete and up-to-date Section 15:
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is essential for the overall completeness of the SDS,
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supports product recipients in meeting the regulatory obligations concerning the product.
Need help with creating a safety data sheet or updating Section 15?
Get in touch with us – at SDS Create, we ensure your documentation is fully compliant with current regulations.
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